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Original Article
Occurrence of aspiration pneumonia in dysphagic children post video
fluoroscopy
Ocorrência de pneumonia aspirativa em crianças disfágicas pós videofluoroscopia
Hellen Nataly Correia Lagos1, Rosane Sampaio Santos2, Adriane Celli3, Edna Marcia Silva Abdulmassih2,
Carlos Alberto do Amaral Medeiros4.
1)
2)
3)
4)
Graduation: Speech Therapist
Masters Degree: Speech Therapist
PhD. Pediatric Gastroenterologist.
Residency: Pediatrics.
Institution:
Universidade Tuiuti do Paraná.
Curitiba / PR - Brazil.
Mailling address: Hellen Nataly Correia Lagos - Rua Santa Catarina, 427 - Apto 24 - Bairro: Água Verde - Curitiba / PR - Brazil - ZIP code: 80620-100 - Telephone:
(+55 41) 8416-2860 - E-mail: [email protected]
Financial support or equipment supplier: Hospital de Clínicas da Universidade Federal do Paraná.
Article received in 2011 March 15th. Article approved in 2011 June 25th.
RESUMO
SUMMARY
Introdução: A literatura relata que quando se trata de avaliação instrumental da deglutição em crianças, sem dúvida, a
videofluoroscopia da deglutição oferece grandes vantagens
sobre o estudo endoscópico (6).
Objetivo: Verificar o risco de pneumonia aspirativa após a
realização do estudo da deglutição por vídeofluoroscopia,
em crianças com disfagia.
Método: Em estudo de corte prospectivo, participaram 16
crianças com idade entre 6 meses e 10 anos, com média de
5,2 anos, encaminhadas para estudo da deglutição por
videofluoroscopia. Foram testadas 4 consistências, pudim,
néctar, mel e líquido. A presença de sinais e/ou sintomas
respiratórios foram avaliados pré e pós estudo da deglutição
por videofluoroscopia, por meio de histórico e exame clínico.
Quando necessário solicitado radiografia de tórax.
Resultados: Das 16 crianças, 5 não apresentaram disfagia.
Em 11 crianças o exame demonstrou 4 com disfagia leve, 2
moderada e 5 grave, conforme Classificação de OTT (1996) Classificação da gravidade da disfagia à videofluoroscopia9.
Das 7 crianças que aspiraram durante a realização do exame,
apenas 1 apresentou sintomas respiratórios após o estudo da
deglutição, porém sem sinais de pneumonia ao exame físico.
Conclusão: Na população estudada, não houve ocorrência
de pneumonia aspirativa após a realização do estudo da
deglutição por vídeofluoroscopia, apesar da ocorrência de
aspiração durante o exame em cerca de 50% dos casos.
Palavras-chaves: transtorno de deglutição, fluoroscopia,
pneumonia aspirativa.
Introduction: The literature reports that when it comes of
instrumental assessment of swallowing in children,
undoubtedly, video fluoroscopy of swallow offers great
advantages over the endoscopic study.
Objective: Check the risk of aspiration pneumonia after the
study of swallowing by video fluoroscopy, in children with
dysphagia.
Method: In a study of prospective cutting, participated 16
children aged between 6 months and 10 years, with an average
of 5,2 years, referred for study of swallowing by video
fluoroscopy. Were tested 4 consistencies, pudding, nectar,
honey and liquid. The presences of signs and/or respiratory
symptoms were evaluated pre and post study of deglutition by
video fluoroscopy, through history and clinical exam. When
necessary was asked chest x-ray.
Results: Of 16 children, 5 didn’t presented dysphagia. In 11
children the exam showed 4 with mild dysphagia, 2 moderate
and 5 severe, as classification of OTT (1996) - Classification
of severity of dysphagia to the video fluoroscopy. Of the 7
children who aspirated during the exam, only 1 presented
respiratory symptoms after the deglutition study, but without
signal of pneumonia to the physical examination.
Conclusion: In the studied population there were no
occurrences of aspiration pneumonia after the study of
deglutition was performed by video fluoroscopy, despite the
occurrence of aspiration during the exam in about 50% of
cases.
Keywords: deglutition disorders, aspiration pneumonia,
fluoroscopy.
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Occurrence of aspiration pneumonia in dysphagic children post video fluoroscopy.
INTRODUCTION
In oropharingeal dysphagia, the complications of
lung diseases caused by aspiration are the most difficult
clinical management. Therefore, the detect ability and the
characterization of this aspiration, which occurs in the
pharyngeal phase, are primary for prognosis and
rehabilitation. The aspiration can be inferred through clinical
evaluation, but its objective confirmation should be done
by video fluoroscopy (1).
The videofluoroscopy of deglutition is considered
the best instrumental method to evaluate deglutition in
children, as it evaluates from the beginning of the oral
preparatory stage to conclusion of esophageal stage (2).
However, studies indicate that children with severe
dysphagia possess high risk in having complications during
the examination (3).
The instrumental exam such as video fluoroscopy is
a great ally to evaluate babies and children with deglutition
disorders. Through this exam we have been observed high
incidence of silent aspiration in radiographics studies
involving children with multiple disabilities (1).
Dysphagia patients have the risk of aspiration raised,
i.e., the passage of food and/or fluids enter below the vocal
cords through the airways, raising the risk of pneumonia and
problems associated (4). Yet according to these authors,
most studies about silent aspiration in dysphagic patient,
supports the use of video fluoroscopy of deglutition for its
detection, considering the most sensitive exam in detection
of aspiration during deglutition (2).
To Langmore (1999) there are three prerequisites
to evolve pneumonia aspiration: a) pathogenic germ
present in the aspirated material; b) the material must be
aspirated and c) the lungs should be unable to resist to the
pathogenic germs (5,6).
In child, without any doubt, the video fluoroscopy
of deglutition offers great advantages over the endoscopic
study, as well as being technically feasible, it practically
reproduces the real situation of deglutition (7).
Despite of advantages, as the analysis accurate and
immediate of deglutition and the non- invasive procedure,
there is for the pediatric population a greater risk than the
adults, as the radiosentivity of the thyroid is known to be
particularly elevated (8).
During the exam, the examiner must observe if
there is or not perception signs of laryngotracheal aspiration,
such as cough, choke, clean the throat and weep. If the
Lagos et al.
patient does not show any of those signs, he will be
considered as a silent aspirator with risk to evolve pneumonia by aspiration (9). Some of the authors refer to close the
examination if it will be any significant aspiration of the
bolus without any cleaning reflex or voluntary cleanup of
the airways, for although barium is considered inert, the
entry of large amount into the respiratory tree is not
recommended, once it could cause problems to the persons
with systemic diseases or respiratory.
This study aims to verify in children with high risk by
accompanying speech therapist and physician the
occurrence of aspiration pneumonia right after the video
fluoroscopy exam.
METHOD
This was a prospective cohort study in 16 children
aged between 06 months and 10 years-old, with an average
of 5,2 years-old, being 50% male and 50% female, with
average weight 14kg with complaints of dysphagia, they
had been referred by the pediatric department for deglutition
study through video fluoroscopy to research dysphagia.
In the description of underlying disease, 13 children
presented Cerebral Paralysis, 01 child with Microcephaly
and 02 children with Encephalopathy.
All of the children who presented the dysphagia
symptoms were referred to study of deglutition by video
fluoroscopy.
The criteria to include the children in this research
were: clinical condition to take examination is awake,
active and with medical permission. It was excluded all of
children who presented pneumonia before taking
examination.
The study was approved by the Ethics in Research
Committee, under nº. 000025/2009, (Annex I).
To collect data about the underlying disease,
dysphagia, signs and pneumonia symptoms cause, it was
used patients´ records and initial interview with children´s
responsible who signed a term authorizing the use of the
data in the research.
It was used the Functional Oral Intake Scale - FOIS,
which follows an scale from Level 1 to Level 7, of which,
less the value is less is the via oral food ingestion (10), in
order to classify the children oral intake.
Before video fluoroscopy examination children were
underwent chest radiography in order to exclude any
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438
Occurrence of aspiration pneumonia in dysphagic children post video fluoroscopy.
possibility of prior pneumonia. The x-ray equipment used
was Siemens - model Axiom R100, monitor Siemens and
model M44-2, which was also used to the video fluoroscopy
of deglutition examination.
In order to perform examination children were
placed sit alone in 90º or, when necessary, on the mother´s
or responsible lap, vision with lateral radiograph.
The consistencies presented were: Pudding, Honey,
Nectar and Liquid, composed of water, Barium Sulfate
(100% Bariogel brand), as radiological contrast which
contains 1g barium sulfate and vehicle g.s.p. 1ml, for
pediatric and adult use, and as thickener we used the
instant modified cornstarch from the brand THICK UP®,
which is composed by modified cornstarch (E1442), malt
dextrin, Tara gum, xanthan gum and guar gum.
Lagos et al.
After examination patients returned within a week
for medical evaluation in order to check if there are signs or
respiratory symptoms and for clinical speech evaluation for
the signs or symptoms of dysphagia, history of aspiration and
clinical conditions by means of a protocol. This period of 07
days to return was set according to the availability of the
targeted group, using the limited days for that evaluation. It
was conducted new chest radiography, when the signs and
respiratory symptoms suggested pneumonia.
RESULTS
From the referrals of deglutition study by video
fluoroscopy of deglutition, 06 children were referred by
Gastroenterologist, 03 by pediatrician, 04 by Speech
Therapist, 02 by Pulmonologist and 01 by Immunologist .
To obtain the consistencies, we used the
nomenclature of National Dysphagia Diet: Standardization
for Optimal Care (11) and the thickner THICK UP®, which
it was used for the nectar (from 51 to 350cP), -200 ml of
water, 2 sachets (10 gr) of THICK UP®, Honey (from 351
to 1750cP) - 200ml of water, 2½ sachets (12,5 gr) of
THICK UP® and for Pudding (> than 1750cP), - 200ml of
water, 3 sachets (15 gr) of THICK UP®. instant food
thickener from brand Thick&Easy® (HORMEL HEATH
LABS. SWISS) composed of starch, nutritional composition
presented as 100g: 375kcal, 100g of carbohydrates and e
125mg of sodium.
Within the 16 children only 02used metal type
tracheotomy and only 01 had been hospitalized.
The utensils used to offer those consistencies were
spoon, glass and bottle in case of the babies.
Related to the via oral by Functional Oral Intake
Scale - FOIS (9), 5 (31,25%) were on N1 (Level 1), 1
(6,25%) on N2, 1 (6,25%) on N3, 6 (37,50%) on N5 e 2
(12,50%) on N7. But the occurrence of aspiration during
the videofluoroscopy it was 7 (43,75%) children, as shown
on Table 1.
In order to record the examination were used
computer from brand HP Pavilion tx2075BR Notebook PC
and for image collector we used Sapphire - Wonder TVUSB.
To classify the dysphagia, we used the Severity of
Dysphagia to Fluoroscopy - OTT (1996), which classifies
as Normal Deglutition, Light Dysphagia, Moderate
Dysphagia and Severe Dysphagia (12).
Before the examination, 04 children presented
respiratory symptoms, cough with phlegm, respiratory
difficulty, fever and dry cough, although without pneumonia diagnosis.
From those patients with respiratory symptoms
before examination, for 02 children the symptoms persisted
after taking the exam and the other 02 children the
symptoms disappeared.
By the classification OTT (11) of the Severity of
Dysphagia to Fluoroscopy, 5 (31,25%) children presented
normal deglutition, 4 (25%) light dysphagia, 2 (12.50%)
moderate dysphagia and 5 (31,25%) severe dysphagia
(Table 1).
Table 1. Relation of oral intake -FOIS, tracheal aspiration during video fluoroscopy and dysphagia classification level
by OTT scale.
Oral intake - FOIS
Tracheal aspiration
Dysphagia classification by OTT
in examination
N1 N2
N3
N4
N5
N6
N7
P
A
Normal
Light
Moderate Severe
5
1
1
0
6
0
2
7 (43,7) 9 (56,2) 5 (31,2) 4 (25,0) 2(12,5) 5(31,2)
Source: Author
Note: FOIS® functional scale for nutrition; A=Absent; P=Present; Patients numbers (%).
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Occurrence of aspiration pneumonia in dysphagic children post video fluoroscopy.
From 7 (43,75%) children whose examination
showed aspiration, 2 (28,5%) simultaneously aspirated
consistencies of pudding, honey, nectar and liquid, other 3
(42,8%) children aspirated honey, nectar and liquid and
finally, 2 (28,5%) aspirated only the consistency of liquid,
as shown on Table 2.
Among 7 (43,75%) children, whose presented
tracheal aspiration during examination, only 2 (28,5%)
presented respiratory symptoms after deglutition study,
however without pneumonia signs on physical examination
(Table 3).
DISCUSSION
In this oropharingeal dysphagia, the complications
of lung diseases caused by aspiration are the most difficult
clinical management. Therefore, the detect ability and the
characterization of this aspiration, which occurs in the
pharyngeal phase, are primary for prognosis and
rehabilitation. The aspiraton can be inferred through clinical
evaluation, but its objective confirmation should be done
by video fluoroscopy (1).
The video fluoroscopy of deglutition is considered
the best instrumental method for evaluation of deglutition
Table 2. Aspiration Occurrence in each consistency tested.
Aspirated consistencies during examination
Pudding/Honey/
Honey/Nectar/
Liquid
Nectar/Liquid
Liquid
simultaneous
simultaneous
2 (28,5)
3 (42,8)
2 (28,5)
Source: Author
Note: Patients numbers (%).
Lagos et al.
in children, therefore it evaluates since the beginning of the
oral phase to the esophageal conclusion phase (2).
Table 1 shows that amongst those 16 children
evaluated, 7 (43,75%) presented tracheal aspiration,
which according to the literature it would be a
potentiating to aspiration pneumonia occurrence, as
AHCPR, U.S. Government Agency, dysphagia patients
who aspire has 50% chance higher to evolve aspiration
pneumonia, compared to the patients who don´t aspire
(5).
Among the survey population, 5 (31,25%)
children were classified with severe dysphagia and
some studies indicate that children with dysphagia
have high risk to develop complications during the
examination (3).
Observing Table 02 in this research, we realized
that in the examination liquid consistency was the most
aspired, and the minor occurrence was the pudding
consistency, indicating that the liquid consistency has
a higher incidence of aspiration which, according to the
literature, it would be another complicating, as the risk
on patients who present aspiration pneumonia rises
when the liquid consistency is aspirated. In a study, in
which there was a retrospective examination of
deglutition video fluoroscopy conducted in 150 children
with deglutition dysfunction, there were more cases of
children with pneumonia who had aspired liquid
consistency, which indicated different results from
those who had aspired thick liquids and purée
consistency, in which pneumonia cases were much
lower (13).
In 7 (43,75%) children who aspired during the
deglutition examination, after a week only 2 (12.50%)
children presented some respiratory symptom, therefore
a child presented the same symptom before the
Table 3. Occurrence of respiratory symptoms after deglutition study in patients with light,
moderate and severe dysphagia.
Signs and
Level of dysphagia by OTT (1996) classification
Symptoms
Light
Moderate
Severe
after examination
A
P
A
P
A
P
Cough with phlegm
4 (100%)
1 (50%)
1 (20%)
Fever
4 (100%)
1 (50%)
4 (80%)
Respiratory difficulty
4 (100%)
1 (50%)
4 (80%)
Nutrition intake
diminishing
4 (100%)
1 (50%)
1 (20%)
Source: Author
Note: A=Absent; P=Present; Patients Numbers (%).
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Occurrence of aspiration pneumonia in dysphagic children post video fluoroscopy.
evaluation, and the other child despite having aspirated
all of the consistencies and being classified with severe
dysphagia, didn´t have positive for pneumonia in
physical examination, contradicting what literatures
had quoted before.
These results also shows the opposite from what
the other authors states (14), which say that one of the
complications in doing studies of deglutition through video
fluoroscopy is that the patient with that disorder can be
exposed to the risk of aspirating the contrast, and in this
present research is possible to observe a few number of
pulmonary complication after examination (Table 3), and
without diagnosis for pneumonia.
With this we can answer to two great questions
which motivated this research:
a) The video fluoroscopy of deglutition examination
increased the risk of pneumonia?
b) The risk benefit justifies the procedure?
It is worthy to clarify here that, during the video
fluoroscopy evaluation, we could only observe a fractional
part of deglutition, and therefore we could not interfere
effectively in the occurrence or not of aspiration during
deglutition, we could only infer if patient had aspired or not
at that fraction of time. Thus, it keep on being the best
method to evaluate deglutition on children, as this present
research showed evidences and safety on the procedure,
even in children with severe dysphagia, and further more,
also it is important to underline that video fluoroscopy may
have on clinical evaluation not only a complementary
nature , but also it helps to determine the therapeutic
approaches in a more objective way (1).
CONCLUSION
Video fluoroscopy of deglutition has been the most
instrumental method used simultaneously to the deglutition
clinical evaluation. But, it is worth to say that is very
important having a specialized multidisciplinary examination
team.
At the present study there are evidences of safety
on this procedure, but in order to affirm this question with
more accuracy, it´s necessary a greater amount of population
researched, leaving it amongst another as a suggestion for
continuing researches in this field, as well as correlate the
examination data with the underlying disease.
In the studied population, there was not occurrence
of aspiration pneumonia after study of video fluoroscopy
of deglutition, despite of occurrence of aspiration during
examination in about 50% of cases (7/16).
Lagos et al.
ACKNOWLEDGEMENTS
Authors thank to Dr. Elmar Allen Fugmann for giving
the sector study, to the speech therapists and radiologist
from the same sector.
BIBLIOGRAPHY REFERENCES
1. Furkim AM, Behlau MS, Weckx LLM. Avaliação clínica e
videofluoroscópica da deglutição em crianças com paralisia
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2. Singh V, et al. Investigation of aspiration: milk
nasendoscopy versus videofuoroscopy. Eur Arch
Otorhinolaryngol. 2009, 266:543-545.
3. Levy DS, Cristovão PW, Gabbi S. Protocolo do estudo da
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Silva LMC. Disfagia: Avaliação e tratamento. RJ: Editora
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Do We Know? Dysphagia. 2005, 20:218-225.
5. Gomes GF. Identificação de fatores preditivos de
pneumonia aspirativa em pacientes hospitalizados com
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Curitiba. 2001 (Tese de Doutorado - Universidade Federal
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6. Marik PE. Aspiration pneumonitis and aspiration
pneumonia. New England J Med. 2001, 344(9):665-671.
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deglutição em crianças. In: Jotz GP, Angelis EC, Barros APB.
Tratado de deglutição e disfagia - No adulto e na criança.
RJ: Editora Revinter, 2009. p.94-96.
8. Maempel IZ, Chapple CL, Leslie P. Radiation Dose in
Videofluoroscopic Swallow Studies. Dysphagia. 2007, 22:1315.
9. Corbin-Lewis K. Liss JM. Sciortino KL. Bases fisiológicas
da disfagia neurogênica e estratégias de tratamento. In:
_____. Anatomia clínica e fisiologia do mecanismo da
deglutição. SP: Cengage Learning, 2009. p.161.
10. Crary MA. A direct intervention program for chronic
neurogenic dysphagia secondary to brainstem stroke.
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11. ADA. National Dysphagia Diet: Standardization for
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Optimal Care. American Dietetic Association. 2002; V-1.
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in Children. Pediatric Pulmonology. 2007, 42:1024-1031.
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Dysphagia. 1996, 11:187-190.
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Annex 1
Occurrence of aspiration pneumonia after the performance of the
swallow study by videofluoroscopy in infants of high risk
Ocorrência de pneumonia aspirativa após realização do estudo da
deglutição por videofluoroscopia em crianças de alto risco
Hellen Nataly Correia Lagos, Rosane Sampaio Santos, Adriane Celli,
Edna Marcia Silva Abdulmassih, Carlos Alberto do Amaral Medeiros
Universidade Tuiuti do Paraná
Curitiba – Paraná – Brasil
Original Article
Introduction: The literature report that when it comes of instrumental evaluation of swallowing in infants,
without a doubt, the video fluoroscopy of swallow offers a great advantage over the endoscopic study,
besides being more feasible, reproduces practically the real situation of a swallow, but there are not reports
from the literature about the risks of a aspiration during the exam potentiate the occurrence of a aspiration
pneumonia (MELLO-FILHO, et al, 2009). Objective: Verify the occurrence of aspiration pneumonia after
the performance of the video fluoroscopy exam, in infants of high risk. Method: Participated of the study
16 children, with age from 6 months to 10 years old, sent with complaints of dysphagia for the area of
pediatrics, for the performance of the swallowing video fluoroscopy exam. Before the exam the children
were submitted to a x-ray of chest to exclude the possibility of a preview pneumonia. Was performed a
comeback after a week for the clinic evaluation and phonological and in the suspicious of a pneumonia were
sent to a chest x-ray. This study was approved by the Research Ethics Committee, under the number:
000025/2009, from University Tuiuti do Paraná. For the classification of the dyphagia, was used the
Classification of Severity of Dysphagia on Video Fluoroscopy from OTT et al. (1996), in which is classified
from Normal, Light dysphagia, moderate and severe. Results: of respiratory symptoms before the exam,
2 children presented cough with mucus and respiratory difficulty, 1 presented fever and dry cough and
1 presented only cough with mucus. As the patients that presented respiratory symptoms only after the
exam, only one patient had aspirated the material of the exam, although he did not have a positive diagnosis
of pneumonia. In regard of the degree of dysphagia, there were 5 normal children, 4 presented light
dysphagia, 2 presented moderate and 5 had severe dysphagia. During the performance of the exam, 7
patients presented aspiration in the liquid consistency, and 2 of them aspirated also in the solid consistency,
4 also aspirated in the pasty consistency and thin paste and the rest did not aspirated.Conclusion: in the
present work we can conclude that, among the researched population there were no occurrence of
aspiration pneumonia after the exam.
Descriptors: swallow disorder; fluoroscopy; aspiration pneumonia.
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Occurrence of aspiration pneumonia in dysphagic children post video fluoroscopy.
Lagos et al.
Anexo II.
TERM OF CONSENT FREE AND INFORMED
You are being invited to participate of a research. The
existent information in this document is for you to understand
perfectly the objectives of the research, and knows that is a
spontaneous participation. If during the reading of this document
you have any doubt you must ask questions for you to perfectly
understand of what is about. After being informed about the
following information, in the case of acceptance to be part of this
study, sign in the end of this document, that contend two ways,
being one yours and the other from the responsible researcher.
Information about the research:
Title of the Research Project: “Occurrence of Aspiration
Pneumonia after the performance of the swallow study by video
fluoroscopy in infants of high risk”.
Responsible researcher: Rosane Sampaio Santos
Contact telephone: (41) 3331 – 7807
INTRODUCTION:
The aspiration functional dysphagia is the most feared
disorder, provoked by aspiration, that is the passage of material
under the vocal folds (BOTELHO, M.I.M.R. SILVA, A.A.,2003), and
when it happens can occur beyond of other problems the aspiration
pneumonia.
The aspiration pneumonia develops after the inhalation of
oropharyngeal contaminated material. Even though of this mechanism
is common to most of pneumonias the expression of aspiration
pneumonia refers to the development of pulmonary infiltrates
radiographically evident in patients with increased risk of
oropharyngeal aspiration (MARIK, P.E.).
The most used procedure for the investigation of dysphagia
is the dynamic study of swallow (LEVY, D.S. CRISTOVÃO, P.W.
GABBI, S, 2004).
GOAL OF THE RESEARCH
This work has as goal verify the occurrence of aspiration
pneumonia after the performance of the video fluoroscopy exam,
in children by means of accompaniment after the realization of the
same.
PROCEDURE
The patient is sent for the sector of endoscopy Peroral from
Hospital das Clínicas – UFPR, for the realization of the swallowing
exam by video fluoroscopy, before the performance of the exam
data of the patient will be collected, through interviews from
parents or responsible ones, and by collected information from the
medical records.
The patient will do the exam, and the data will be collected
by means of protocol.
In one week the patient must return to the same sector for
the accompaniment of a speech therapist and pediatric, and will be
evaluated in regard of the signs of dysphagia, history of aspiration
and clinical conditions, and when necessary will be sent to a chest
x-ray, to confirm the pneumonia by aspiration.
RISKS AND BENEFITS
The exam is quick and painless. The findings of this research
can elucidate questions about the risks of pneumonia after the
realization of the exam, being that this exam has great diagnostic
importance for the evaluation of dysphagia.
DISCOMFORT
The exam of swallow by video fluoroscopy has as
inconvenient the flavor of the consistencies that will be presented,
composed by water and barium sulfate.
COSTS
You will not have any spent with the research, because it
will be funded by the researcher itself.
PARTICIPATION
In case you want to quit from the participation of the
research, you can do it at any time and moment you want to. All
the participants of the research will be evaluated by the researcher:
Hellen Nataly Correia Lagos graduate from the course of
phonoaudiology in which will be under orientation from the speech
therapist Rosane Sampaio Santos.
During the ongoing of the research, in case you have any
doubt or need a extra orientation use the telephone above.
PRIVACY AND CONFIDENTIALITY
You have the commitment of the researcher that your
image and identity will be preserved in absolute secret.
RESPONSIBILITY
In case of any damage during the research, the researchers
Rosane Sampaio Santos and Hellen Nataly Correia Lagos are
responsible by the eventual reimbursements.
In case of new information during the research, they will
be submitted to the evaluation from the Ethics Committee for a new
insight.
DECLARATION OF CONSENT
I, _____________________________________________,
carrier of the RG:_____________________________, signed below,
agree that my child______________________________________
participate of the study above described as a subject.
I was properly informed and enlightened by the researches
Hellen Nataly Correia Lagos and Rosane Sampaio Santos about the
research and the contained procedures in it.
I was assured that, I can retrieve my consent at any moment,
without this leading for some kind of penalty.
Curitiba, __/__/____.
____________________________________________________________________________
Signature of the responsible
____________________________________________________________________________
Signature of the responsible researcher
Intl. Arch. Otorhinolaryngol., São Paulo - Brasil, v.15, n.4, p. 437-443, Oct/Nov/December - 2011.
443